Breast Cancer.
Conditions
Interventions
Intervention 1: Intervention group: Participants in this study will undergo a fasting-mimicking diet (FMD) with a high-fat and low-carbohydrate composition, along with a daily dose of 2 grams of omega
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Individuals aged over 18 years who have recently received pathological confirmation of breast cancer and require surgical removal of the cancerous tumor. Patients with a WHO performance status of 0 to 2. Willingness to cooperate. Gender: Female. Age: Between 18 and 75 years. Provision of documented informed consent personally signed and dated by the patient, indicating that the patient has been informed of all relevant aspects prior to enrollment in the study. Willingness and ability to comply with the prescribed diet, scheduled visits, treatment plans, laboratory tests, and other study procedures. Patients with clinical stage I–III breast cancer according to TNM classification. Patients with stage I TNBC will be included only if the primary tumor is at least 10 mm in its greatest dimension (clinical T1c as determined by baseline MRI assessment). Platelets = 100000 Hemoglobin = 9 g/dL Calcium (albumin-corrected serum calcium) within the normal range Potassium within the normal range, or corrected with supplements Creatinine < 1.5 × the upper limit of normal (ULN) Blood uric acid < 10 mg/dL ALT and AST < 2 × ULN Total bilirubin < 1.5 × ULN Fasting glucose < 250 mg/dL
Exclusion criteria
Exclusion criteria: Diagnosis of diabetes or any disorder affecting glucose metabolism. Absolute neutrophil count (ANC) less than 1500 and platelet count less than 90,000. Weight loss greater than 10% during the past 3 months. History of systemic therapy for breast cancer or other malignancies within 5 years prior to study entry. Prior treatment with anthracyclines. Body mass index (BMI) less than 20 kg/m². History of alcohol abuse. Unintentional weight loss greater than or equal to 5% in the past 3 months, unless the patient has BMI Greater than 22 kg/m² and weight loss at study enrollment is less than 10%; or unintentional weight loss greater than or equal to 10% in the past 3 months, unless the patient has BMI greater than 25 kg/m² and weight loss at study enrollment is less than 15%. In both cases, body weight must have been stable for at least one month prior to enrollment in the study. Active pregnancy or breastfeeding. Serious infections within 4 weeks prior to starting the diet, including possible hospitalization due to infection-related complications, bacteremia, or severe pneumonitis. Active autoimmune diseases requiring systemic treatment (e.g., systemic steroids or immunosuppressive medications). Recent diagnosis of hypothyroidism requiring systemic hormone replacement therapy, with an unstable hormonal profile (including fT3, fT4, and TSH) not yet stabilized within the normal range. Diagnosis of type 1 or type 2 diabetes requiring pharmacological treatment (including insulin, insulin secretagogues, and metformin). A diagnosis of type 2 diabetes that, according to an endocrinologist, does not require pharmacological treatment is compatible with enrollment in this study. Fasting plasma glucose at baseline less than or equal to 60 mg/dL. Active peptic disease, nausea, vomiting, uncontrolled diarrhea, malabsorption syndrome, or surgical resection of parts of the small intestine. History of cardiovascular disease including: Angina pectoris, coronary artery bypass surgery, symptomatic pericarditis, or myocardial infarction within 12 months prior to initiation of the experimental treatment, congestive heart failure History of significant cardiac arrhythmias such as ventricular tachycardia, chronic atrial fibrillation, complete bundle branch block, high-grade atrioventricular block such as bifascicular block, Mobitz type II block, third-degree atrioventricular block, nodal arrhythmias, or supraventricular arrhythmias. Left ventricular ejection fraction less than 50% on radionuclide cardiac scan or echocardiography. History of episodes of symptomatic hypotension leading to loss of consciousness. Underlying medical or psychiatric conditions that, in the investigator’s opinion, make the patient unsuitable for participation in the clinical trial. Other cardiac, hepatic, pulmonary, or renal diseases not mentioned in the previous inclusion or exclusion criteria but that could potentially place the patient at high risk for lactic acidosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean PD-L1 level in blood. Timepoint: before and after the intervention. Method of measurement: Immunohistochemistry.;Mean CD8 level in blood. Timepoint: before and after the intervention. Method of measurement: Immunohistochemistry.;Mean CD4 level in blood. Timepoint: before and after the intervention. Method of measurement: Immunohistochemistry.;Quality of life score. Timepoint: before and after the intervention. Method of measurement: EORTC QLQ-C30 & EORTC QLQ – BR23 Questionnaires.;Lymphedema score. Timepoint: before and after the intervention. Method of measurement: ICF – QLR Questionnaire.;Surgery-related infection. Timepoint: before and after the intervention. Method of measurement: Asepsis Scoring System. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdi Amirpour
Shahid Beheshti University of Medical Sciences
Outcome results
None listed